INTERNATIONAL JOURNAL OF LATEST TECHNOLOGY IN ENGINEERING,
MANAGEMENT & APPLIED SCIENCE (IJLTEMAS)
ISSN 2278-2540 | DOI: 10.51583/IJLTEMAS | Volume XIII, Issue VI, June 2024
www.ijltemas.in Page 63
“Emerging Occupational Risks in a Pharmaceutical Company Under
Industry 4.0: An Assessment Using TICHNER and HIRAC Tools”
Victoria Joy Pama, Francispito Quevedo, Venusmar Quevedo
College of Engineering, Adamson University
DOI : https://doi.org/10.51583/IJLTEMAS.2024.130609
Received: 31 May 2024; Revised: 15 June 2024; Accepted: 21 June 2024; Published: 15 July 2024
Abstract: The integration of Industry 4.0 technologies within the pharmaceutical manufacturing sector aligns with broader industrial
objectives, aiming to enhance productivity and adaptability while meeting challenging standards for product quality and diversity
while maximizing efficiency. However, this shift is not risk-free. This particularly concerns the well-being of workers which is one
of the top concerns shared by manufacturers. As the industry navigates this transition, it is imperative to prioritize the safety of
personnel. The rapid pace of technological innovation within pharmaceutical manufacturing carries significant implications,
introducing new and emerging risks. Consequently, proactive identification and assessment of these potential threats are essential to
effectively mitigate their impact and ensure preparedness for forthcoming changes. To address this gap, this study provides an
approach for identifying potential sources and significant factors contributing to its increasing risks in implementing Industry 4.0 in
manufacturing industries. This set of sources and factors was evaluated in a medium-sized pharmaceutical manufacturing company
aided by TICHNER and HIRAC Tools through a mixed-method approach. The combination of these tools facilitates the
identification, characterization, and analysis of new and emerging risks associated with Industry 4.0 implementation. The findings of
the study showed that Psychosocial Hazards and Work Experience/ Knowledge are the most common potential sources of
Psychological Risks, Unemployment, and Need for Qualified Workers. The approach will allow manufacturers to proactively
manage the new and emerging challenges brought by Industry 4.0 and safeguard the well-being of the workforce.
Keywords: Industry 4.0, Pharmaceutical, Manufacturing, Occupational Safety and Health, and Risk Assessment.
I. Introduction
The pharmaceutical manufacturing industry stands at the forefront of transformative change as it integrates the principles and
technologies of Industry 4.0 into its operations [1]-[2]. Industry 4.0, often referred to as the Fourth Industrial Revolution, represents a
paradigm shift marked by the fusion of digital, physical, and biological systems. In the context of pharmaceuticals, this revolution
manifests through the seamless convergence of revolutionary technologies, including automation, artificial intelligence (AI), the
Internet of Things (IoT), and data analytics [3]-[4]. Traditionally characterized by rigorous regulatory standards, precision, and a
focus on product quality, the pharmaceutical sector is leveraging Industry 4.0 to enhance its efficiency, flexibility, and overall
competitiveness [1]. However, this industrial revolution also introduces a critical dimension that demands careful consideration —
the impact on occupational health [5].
As pharmaceutical facilities increasingly embrace the principles of Industry 4.0, the nature of work within these environments
undergoes substantial changes. Automation and digitalization bring forth new opportunities for productivity but concurrently
introduce new challenges to the well-being of the workforce [6]. This study seeks to explore and understand the potential
occupational health risks stemming from the implementation of Industry 4.0 in pharmaceutical manufacturing.
By examining this intersection, this study aims to provide insights into how the merging of revolutionary technologies with
traditional pharmaceutical processes may affect the physical and mental health of employees. The study recognizes the importance of
safeguarding the workforce in an era of rapid technological advancement, ensuring that the pursuit of operational excellence aligns
with the preservation of employee health and safety. As the pharmaceutical industry embraces Industry 4.0, this investigation
becomes essential for fostering a workplace environment that is not only technologically advanced but also inherently protective of
its most valuable asset — its people.
Understanding the perception gap between employers and employees regarding Occupational Health Risks is one of the gaps that
this study wants to address.
II. Objectives
The objectives of the study are to identify the sources of New Occupational Health Risks, and determine the significant factors
contributing to the increasing risk of New Occupational Health Hazards in the integration of Industry 4.0 in a medium-sized
Pharmaceutical Manufacturing Company, and recommend safety programs and controls for the mitigation of New and Emerging
Occupational Health Risks resulting in the integration of Industry 4.0.
Scope and Limitations
This study is limited to identifying potential occupational health risks associated with the implementation of Industry 4.0
technologies focusing on a pharmaceutical manufacturing company through related literatures and is limited to a medium-sized
pharmaceutical manufacturing company utilizing a semi-automated production of sterile parenteral. Risk Analysis pursued in this
study will only include the identified and characterized new and emerging occupational health risks after using the TICHNER Tool.
A qualitative analysis will be incorporated into the identification and characterization of NERs using the TICHNER Tool while a
quantitative analysis will be applied using the HIRAC Tool. The data gathering will utilize a survey instrument to be distributed to
INTERNATIONAL JOURNAL OF LATEST TECHNOLOGY IN ENGINEERING,
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ISSN 2278-2540 | DOI: 10.51583/IJLTEMAS | Volume XIII, Issue VI, June 2024
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the manufacturing company. The concepts of the HIRAC tool will be used as the basis for recommending the appropriate controls for
the elimination or minimization of risks.
Industry 4.0 in OSH
The study by Zorzenon et al. (2022) showed that Industry 4.0 has positive and negative impacts on Occupational Safety and Health.
The study identified that a safer work environment and mitigation of occupational risks are the potential positive impacts of Industry
4.0. However, the negative impacts are increased stress, fatigue, diseases, musculoskeletal problems, and psychosocial risks [7].
Leso et al. (2018) provides a comprehensive overview of the opportunities and problematical aspects of Industry 4.0 concerning
workers' safety and health. The study showed that the opportunities given by Industry 4.0 to OSH are better work-home interface,
less monotonous work, enhanced HMI for hazardous tasks, safer and healthier work conditions, monitoring of employees' well-
being, and Smart PPE [8]. Fig. 1 shows the diagram of Opportunities of Industry 4.0.
They also discussed the potential issues of Industry 4.0. The widespread automation in Industry 4.0 manufacturing jobs will
inevitably lead to a reduction in manual work and hard physical tasks as well as to an increase for the entire workforce in complex
management, abstraction, and problem-solving demands in the case of unforeseen events. Psychological risks will become more
evident than physical ones in the workplace due to mental overload and work density induced by even more flexible and dynamic
smart manufacturing activities. Fig. 2 shows the diagram of the issues and concerns deriving from the applications of Industry 4.0 in
workplaces.
Fig. 1 Opportunities of Industry 4.0
Fig. 2 Issues and Concerns of Industry 4.0 in Workplaces.
Industry 4.0 and the Pharmaceutical Manufacturing in the Philippines
In 2019, a report by Klynveld Peat Marwick Goerdeler (KPMG) stated that the Philippines is the 11th most attractive pharmaceutical
market in the Asia-Pacific region and the third-largest pharmaceutical market in ASEAN, after Indonesia and Thailand. The
country’s pharmaceutical industry is projected to grow by 4.5 percent annually over the next five years, reaching P164 billion in
2018 from P146 billion in 2014, representing the value output or production of the industry, including research-based pharmaceutical
and generic companies. This shows that Filipino pharmaceuticals is one of the fastest-growing industries in the country and has
grown year to year [9].
The pharmaceutical manufacturing industry benefits significantly from the integration of Industry 4.0 applications for several
reasons. However, it also introduces occupational health challenges [10]-[11].
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Potential Occupational Health Risks in Industry 4.0
The following potential occupational health risks were derived from the study of Leso et al. (2017). These risks will be the basis of
the study to identify the New and Emerging Occupational Health Risks in the implementation of Industry 4.0 technologies. The study
stated that these will be the potential issues to arise once Industry 4.0 is to be applied.
According to the International Labour Organization (ILO, 2011), occupational health risks stem from occupational health hazards
[12]. Ergonomic Hazards, Physical Hazards, Chemical Hazards, and Psychosocial Hazards are common occupational health hazards
[13]. Thus, this study put to the test whether these hazards could contribute to the increasing risk of New Occupational Risks in the
Integration of Industry 4.0.
Additional factors such as demographics [14], work experience/ knowledge [15], and job position [16] were included as
Occupational Health Hazards.
Psychological Risks
Psychological risks in the application of Industry 4.0 in pharmaceutical manufacturing can indeed be considered occupational health
risks. The implementation of advanced technologies, automation, and digitalization in the workplace can introduce various
psychological stressors and challenges for workers, affecting their mental well-being.
For example, the rapid pace of technological change and the need to constantly adapt to new systems and processes can lead to
technostress, which is the stress caused by the use of technology [17]. Workers may feel overwhelmed, anxious, or even insecure
about their abilities to keep up with evolving technological demands, which can negatively impact their mental health.
Furthermore, job insecurity resulting from automation and the fear of being replaced by machines can also contribute to
psychological distress among workers [18]. The uncertainty about the future of work and concerns about job stability can lead to
feelings of anxiety, depression, and decreased job satisfaction.
Unemployment
According to the World Health Organization (WHO), unemployment can be considered as an occupational health risk. While it may
not be traditionally viewed as a workplace hazard, unemployment has been recognized as a significant factor affecting individuals'
health and well being, including their mental and physical health. The stress, financial strain, loss of social support, and other
negative consequences associated with unemployment can have profound effects on individuals' health.
The adoption of Industry 4.0 technologies such as artificial intelligence, robotics, and automation can lead to job displacement as
tasks previously performed by humans are automated. This phenomenon, known as technological unemployment, can contribute to
increased stress, anxiety, and depression among workers who fear losing their jobs or struggle to adapt to new roles. Technological
advancements have contributed to widening income inequality and job polarization, which can aggravate occupational health risks
[19].
Need of Qualified Workers
From the European Agency for Safety and Health at Work (EU-OSHA 2019), in industries transitioning to Industry 4.0, there is
often a demand for workers with specialized skills in areas such as data analytics, automation, and digital technology. This demand
may lead to increased pressure on existing workers to upskill or adapt to new technologies, potentially resulting in stress and
burnout. Additionally, if there is a shortage of qualified workers, it may lead to understaffing or overworking of existing employees,
which can increase the risk of workplace accidents and injuries.
While there may not be direct references specifically linking the need for qualified workers in Industry 4.0 in pharmaceutical
manufacturing to occupational health risks, studies on workforce development, labor shortages, and occupational stress in high-tech
industries could provide relevant insights.
Privacy Invasion
Privacy invasion in the application of Industry 4.0 in pharmaceutical manufacturing can be considered an occupational health risk,
particularly concerning workers' mental well-being and stress levels.
The implementation of Industry 4.0 technologies, such as the Internet of Things (IoT) and data analytics, may involve the monitoring
and collection of personal data from workers, including their performance metrics, biometric data, and even their physiological
responses.
This invasion of privacy can lead to feelings of mistrust, anxiety, and stress among workers, especially if they perceive their privacy
rights to be violated or if they fear repercussions based on the data collected about them. Additionally, concerns about the misuse or
unauthorized access to personal data can further intensify stress levels and contribute to a negative work environment [20].
Reduced Inter-human Contact
The digitization of work processes and the rise of remote work arrangements can contribute to social isolation, with remote workers
experiencing feelings of loneliness and disconnection from their colleagues [21]. Lack of social support and limited opportunities for
interpersonal interaction may further exacerbate feelings of isolation, impacting mental health and job satisfaction.
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The Case Company
The case company is a medium-sized wholly-owned Filipino company that manufactures Sterile Powder for Injection. Its
manufacturing facility is designed for Aseptic Processes to ensure sterility of its products. The company is always committed to
strictly complying with cGMP and FDA Guidelines to maintain its operations.
The company has been serving people with high-quality pharmaceutical products. As processes evolve and Industry 4.0 concepts are
applied, regulations and standards also change. Moreover, because of the company's commitment to complying with changing
standards and regulations, the company makes an effort to improve its facilities and processes, especially since the activity designed
for its facility is a critical manufacturing activity for pharmaceutical manufacturing.
With the growing demand for drugs and strict compliance with standards, the company has taken a step to move forward and keep up
with other companies in the growing revolution of advanced manufacturing where concepts of Industry 4.0 are applied.
The manufacturing and warehouse building processes will apply Automated Controls, Digitization, Internet of Things, and Real-
Time Monitoring. The reasons for the company’s shift to advanced manufacturing are compliance with standards and regulations,
boosting its stand as the leading local pharmaceutical manufacturing company in the Philippines, and improving its efficiency in
producing high-quality pharmaceutical products. The company’s ongoing project and shift made it a suitable case company for the
study. Additionally, the following characteristics are the basis for selecting the case company:
The Facility is designed for Aseptic Processes
Because of the criticality of its processes, embracing Industry 4.0 is essential to improve efficiency, quality, agility, and sustainability
while remaining compliant with regulatory requirements and driving innovation in the dynamic healthcare landscape. This checks the
criteria that the case company is expected to follow on the transition to Industry 4.0.
Currently Operates in a Semi-Automated System.
The company is currently implementing a semi-automated filling operation of sterile antibiotics in which human intervention in the
process is applied, especially in transferring sterilized packaging materials. A process flow of the current operation is shown in Fig.
3. The involvement of workers in the production will ensure that the data gathered is based on their opinions and first-hand
experiences in the production.
Ongoing Transition to Fully-Automated System
With the rapid advancement of technology, regulatory bodies also change their standards to adapt to the trend. Furthermore,
regulatory compliance is crucial in the pharmaceutical industry, where strict guidelines ensure the safety and efficacy of medications.
Companies must adhere to these regulations while implementing advanced automation.
With the changing technology and regulations, the case company has an ongoing plant expansion and plans to incorporate new
technologies into its operations. The company is expanding where the operations will be fully automated and human intervention is
only at the beginning of the process. Fig. 4 shows the expected process flow diagram of the fully automated Powder Filling
Operation.
This checks the criteria that the company needs to have a risk assessment before implementing the new processes that are integrated
with new technologies.
Fig. 3 Semi-Automated Sterile Filling Operation
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Fig. 4 Expected Flow Process Diagram
Personnel across the manufacturing system are potential sources of contamination. Lack of appropriate training with aseptic
practices, unauthorized access into controlled areas, and personal cleanliness are a few of the areas in which personnel can
compromise sterile production. Thus, the Quality Risk Assessment is the usual risk assessment done in the Pharmaceutical
Manufacturing Industry. Likewise, this research wants to assess the Safety and Health of the employees during production, especially
in the advanced automated processes that are now rampant in any Manufacturing Industry.
Tichner Tool
In the research study conducted by Brocal et al. (2018), they developed a technique aimed at identifying and characterizing new and
emerging risks that are generated in the automated manufacturing process besides the traditional occupational risks. It is based on the
theoretical framework proposed by Brocal et al. (2017), with special consideration given to their definitions and risk models.
TICHNER can be considered part of the risk assessment process described by standard ISO/IEC 31010:2009. This process consists
of the stages of identification, analysis, and evaluation of the risk. How this process is applied depends on the context of the risk
management process and on the methods and techniques used to conduct the risk assessment. The application context of TICHNER
will be configured by a manufacturing process. TICHNER can be applied at any stage of the lifecycle of a manufacturing process. It
may also be used in conjunction with other risk identification techniques [22]-[28].
In the analysis conducted by Fernandez et al. (2015), risk can be considered NER if the conditions developed are satisfied by that
identified risk [29]. The following are the conditions developed:
The risk is “NEW” if:
C1:
Th e risk did not pr eviously exist and is caused by new processes, n ew technologies, new types of
workplaces, or social or organizational change.
C2:
A long-standing issue is newly considered as a risk due to a change in social or public perceptions.
C3:
New scientific knowledge allows a long-standing issue to be identified as a risk.
The risk is “INCREASING” if
C4:
Th e number of hazards leading to the risk is growin g.
C5:
Th e exposure to the hazard leading to the risk is increasing (exposure level and/or the number of
people exposed.
C6:
Th e effect of the hazard on workers' h ealth is getting worse (seriousness of health effects and/or
th e number of people affected).
Because NER is defined as "any occupational risk that is both new and increasing," it follows that for a given configuration, NER
must be satisfied at least one of the conditions that determine a new risk (coded C1 to C3) and another at least of the conditions
relating to when a risk is increasing (coded C4 to C6). References [27] and [29] concluded that Industry 4.0 brings numerous
advantages. However, this paradigm also carries emerging risks and challenges related to organizational and human performance.
These emerging risks include both industrial risks and occupational risks. Arguably, the human factor is the main link between
industrial emerging risks and occupational emerging risks in the Industry 4.0 context. They also recommended a need for case
applications to articulate clearly the potential of approaches developed by the authors.
HIRAC Tool
Hazard Identification, Risk Assessment, and Controls (HIRAC) is a structured process for identifying hazards and specifying actions
to mitigate these hazards for a work activity or task with controls. The risk assessment process provides a method for assessing the
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likelihood of health, safety, and environmental impacts of potential operating risk events. It enables a common approach to the
prioritization and management of risk [22], [30]-[33].
The qualitative risk assessment is the most widely used technique and is mostly a group effort involving experts with various
competencies and experience in factors. Sometimes, companies or individuals have to reply to the information that qualitative may
not give, so it is better to go with an alternate method. While a quantitative technique is largely used in the engineering and
fabrication phases [34]-[36].
The following tables and figures were based on the. Guidelines for hazard identification, risk assessment and risk control (HIRARC)
of the Department of Occupational Safety and Health Malaysia, 2008. The following tables and figures are also widely used in the
Risk Assessment of Occupational Safety and Health in the Philippines.
Table 1 Likelihood Table
Likelihood
Example
Rating
Possible
Th e most likely result of the hazard/event being realized
5
Most Likely
Has a good chance of occurring and is not unusual
4
Conceivable
Might occur at some time in future
3
Remote
Has not been known to occur after many year s
2
Inconceivable
Is practically impossible and has never occurred
1
Table 2 Severity Table
Severity
Example
Rating
Catastrophic
Numer ous fatalities, irrecoverable property damage and
productivity
5
Fatal
Approximately one single fatality major property damage if the
hazard is realized
4
Serious
Non-fatal injury, permanent disability
3
Minor
Disabling but n ot permanent injur y
2
Negligible
Minor abrasions, bruises, cuts, first aid type injury
1
Fig. 5 Risk Rating Matrix
Fig. 6 Hierarchy of Controls
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Theoretical framework
References [7] and [8] concluded that Automated Production Operation in Industry 4.0 would result to an Improved Workplace
Safety where occupational safety risks are minimized. However, the application of this process also results in New Occupational
Health Risks – Psychological Risk, Unemployment, Invasion of Privacy, Need for Qualified Workers, and Reduced Inter-human
Contact. From references [13]-[16], some factors have the potential to affect the increasing risks, and these risks will eventually
become New and Emerging Occupational Health Risks.
These risks need to be systemically identified and characterized to have a proper assessment and control of the risks.
Fig. 7 Theoretical Framework
Conceptual framework
This study’s conceptual framework is to systematically identify and characterize the New and Emerging Occupational Health Risks
in the application of Industry 4.0 concepts in the pharmaceutical manufacturing processes using the TICHNER Tool formulated by
Brocal et al. (2018) and to assess and control these risks using the HIRAC Tool. In the application of the recommended control,
controlled hazards and a safe and healthy workplace will be hypothetically attained.
In the identification and characterization phase using the TICHNER Tool, Traditional Risks, New Risks, Increasing Risks, and New
and Emerging Risks will be recognized. However, this study will only characterize the potential occupational health risks from the
study of Leso et al. (2018). All of which will be considered New Risks. Following the result of the data analysis using the Statistical
Tools, these new risk can be characterized as both new and increasing risks.
New and Emerging Risks will be assessed in this study as stated in the scope and limitations. Recommended controls for the
mitigation of these NERs will follow the Hierarchy of Control.
Fig. 8 Conceptual Framework
III. Methodology
A. Research Design
The data gathering will utilize a survey instrument to determine the increasing risks and the factors that contribute to these risks.
Scoring of the weighted average will be used to identify the sources of the risks. On the other hand, the Chi-Square Test for
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Independence will be used to identify the significant relationships between the sources and demographics of the New and Emerging
Occupational Health Risks. This research will make use of the qualitative approach for the identification and characterization of risks
and the quantitative method for the assessment of risks. Two (2) tools will be used for Risk Identification and Characterization, and
Risk Assessment and Control. The first tool is the Technique to Identify and Characterize New and Emerging Risks (TICHNER)
Tool. This will systematically identify and characterize the risks associated with an automated production process. After NERs have
been identified, the second tool which is the Hazard Identification, Risk Assessment, and Control (HIRAC) Tool, will be used to
assess them. Recommendations for risk control will be made after the risk assessment. Risk scoring will be applied to correlate and
summarize the overall risks identified in the survey. The order of the suggested safety controls and practices will follow the
Hierarchy of Controls.
Published Reports and Studies
Published reports and studies on potential Occupational Health Risks brought by Industry 4.0 will be reviewed and will be the basis
for the preparation of the survey questionnaires.
Survey
Google Forms will be used as the survey hosting platform due to its ability to remain anonymous, highly customizable layout, and
proven data collection reliability. If needed, survey questionnaires will be distributed within the organization. This survey will be
used to gather the data needed for the study. The survey will contain questions intended to be answered by the respondents. The
answers of the respondents will be the basis for the assessment, analysis, and discussion of results. The survey will be divided into
four (4) Sections. The first section will focus on demographics, the second section will focus on dichotomous questions, and the third
section is a 5-point Likert-type Rating Scale. These will be used to identify and assess the hazards and risks from the perspective of
the respondents. The fourth section will be an open-ended question requiring their insight on issues related to the study.
Statistical Analysis
To help with the quantitative analysis of the data gathered from the survey, Statistical Package for the Social Sciences (SPSS) will be
used to organize and analyze the data. Scoring will be used to identify whether potential factors are sources of New and Emerging
Occupational Health Risks. A passing score of seventy percent (70%) will be assigned. The Chi-Square Test of Independence
determines whether there is an association between categorical variables. It will be used in this study to test whether the potential
sources and demographics are related or independent of New and Emerging Occupational Health Risks. Cramer’s V will be used to
measure how strongly the sources and demographics are associated with New and Emerging Occupational Health Risks.
Data Collection
The data collection process involves deploying a survey instrument outlined to assess and address occupational health risks
stemming from the integration of Industry 4.0 technologies within production operations in the pharmaceutical manufacturing sector.
This survey is designed to gather insights from operators and production personnel directly engaged in the manufacturing processes.
It encompasses a spectrum of questions created to explore the specific occupational health hazards introduced by Industry 4.0,
focusing on factors such as work experience and knowledge, Ergonomic, Psychosocial, Physical, and Chemical.
The survey instrument aims to extract firsthand experiences and perceptions related to the physical, mental, and ergonomic health
risks attributed to the adoption of these technologies. Furthermore, it aims to identify challenges posed by rapid technological
changes, employee adaptability, and the overall impact on occupational well-being within the production sphere. By taking employee
perspectives and concerns, this survey strives to provide a holistic view of occupational health, enabling targeted interventions and
proactive measures to mitigate risks while promoting a safer and healthier work environment within pharmaceutical production
operations.
Specifically, the survey will target the participation of a pharmaceutical manufacturing company operating in a semi-automated
production of sterile parenteral. Including this pharmaceutical company will ensure an understanding of the challenges and
opportunities inherent in integrating advanced technologies within the industry, thereby enriching the survey's findings and insights.
Demographic Profile
50.79
%
49.2
1%
Gender
Male Female
9.52
%
39.68%
42.86
%
7.94
%
Age
18-25 years old 26-35 years old
36-45 years old 46-65 years old
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Based on the profile of the respondents, the following are observed:
There is an insignificant difference in the number of male and female workers employed in the production area of the case company.
There are thirty-two (32) male and thirty-one (31) female workers employed.
Ages between 26-35 years old and 36-45 years old are the dominant age group of the respondents. 25 respondents were from the age
group of 26-35 years old while 27 respondents were from the 36-45 years old age group. From the 2020 statistics conducted by the
Philippine Statistics Authority (PSA), the 25-34-year-old age group made up the biggest share of the employed at 27.3 percent,
followed by the 35-44-year-old group at 23.4 percent. The employment rate was also higher among men compared to women.
The highest number of respondents were employees working 0-3 years in the company. However, the combination of respondents
working in the company for 4 years and beyond had a total of 37. This shows that the respondents' profiles have sufficient experience
in production operations, thus making their answers and opinions dependable.
The highest number of respondents were the laboratory operators followed by the machine operators and inspectors. These job
positions are highly immersed and involved in production operations. This shows that respondents have first-hand experience with
the risks during the operations and will have a greater impact in the application of Industry 4.0 in the processes
IV. Data Analysis and Procedure
Fig. 9 Proposed Mixed-method Approach
V. Findings and Results
A. Test for reliability
Reliability is a basis of comprehensive research methodology, ensuring that the measurements and instruments used consistently
yield accurate and consistent results. In research, reliability refers to the extent to which a particular measure or instrument produces
41.27%
7.94
%
23.81
%
26.98%
Length of Service
0-3 years
4-6 years
7-10 years
more than 10 years
1.59%
6.35%
26.98%
36.51%
28.57%
Job position
Manager
Supervisor
Machine Operator
Laboratory Operator
Inspector
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stable and consistent results over time, across different conditions, and among different observers or raters. A reliable test or measure
instils confidence in the validity and credibility of research findings, enabling researchers to draw meaningful conclusions and make
informed decisions based on their data. The purpose of testing the reliability of data is to ensure that the information used for
research, analysis, or decision-making is dependable, consistent, and free from significant errors or biases.
In this study, the researcher tested the reliability of the data gathered before proceeding to the analysis. Cronbach's alpha was used to
test the reliability of the data gathered. The measurement of Cronbach's alpha is used to evaluate internal consistency, which is the
degree of how closely related a group of items are as a whole.
Cr onbach’s Alpha
Reliability Level
More than 0.90
Excellent
0.80-0.89
Good
0.70-0.79
Acceptable
0.6-0.69
Questionable
0.5-0.59
Poor
Less than 0.59
Unacceptable
The data was run on SPSS to test the reliability. The Cronbach’s alpha determined was 0.825 for the 63 valid cases. This means that
the level of reliability of the instrument is good and reliable.
B. Potential Sources
The potential sources or Occupational Health Hazards gathered from the review of the literature were Work Experience/ Knowledge,
Ergonomic Hazards, Psychosocial Hazards, Physical Hazards, and Chemical Hazards. These sources were put under investigation to
know whether these potential sources will exist or not in the current and future production setup. The questions were categorized in
each potential source and were given correct answers. Respondents must have a 70% score for each potential source to conclude that
it is a hazard. Table 3 shows the result of whether a hazard is a source or not a source.
Table 3 Summary of Potential Sources
Potential Sources
Source
Not a Source
Total
f
%
f
%
f
%
Work Experience/ Knowledge
44
69.84
19
30.16
63
100.00
Ergonomic Hazards
42
66.67
21
33.33
63
100.00
Psychosocial Hazards
46
73.02
17
26.98
63
100.00
Physical Hazards
36
57.14
27
42.86
63
100.00
Chemical Hazards
13
20.63
50
79.37
63
100.00
C. Significant factors
The Chi-Square Test for Independence was used to test whether the potential sources and demographics are significantly related to
Occupational Health Risks. The decision rule for the evaluation is “there is no significant relationship if the p-value is less than or
equal to alpha (0.05)”. Cramer's V was used to identify the strength of the relationships. Table 4 shows the summary of the
significant factors that resulted from the test.
Table 4 Summary of Significant Factors
Variables Tested
Chi Square
p-value
Interpretation
Cramer's V
Interpretation
Psych
ologic
al
Risk
(Stress
)
Work Experience/ Knowledge
0.025
Significant
relationship
0.421
very str ong
relationship
Psychosocial Hazards
0.003
Significant
relationship
0.500
very str ong
relationship
U
ne
m
pl
o
y
m
en
t
Work Experience/ Knowledge
0.047
Significant
relationship
0.338
very strong
relationship
Need
for
Qualif
ied
Worke
rs
Work Experience/ Knowledge
0.004
Significant
relationship
0.464
very str ong
relationship
Psychosocial Hazards
0.013
Significant
relationship
0.414
very str ong
relationship
D. Risk Assessment
The TICHNER Tool was used to characterize and present the new and emerging occupational health risk. Characterization of NERs
involves a qualitative method that assesses indicators that contribute to the increasing risks. The factors discussed below are the
components of Industry 4.0. Work Experience/ Knowledge and Psychological Hazards were only considered in the characterization
of NERs because they are the only factors that have significant relationships with the identified risks. The following tables show the
summary of the results of the components that help characterize these new and emerging risks. Characterization of the NER is
directly linked to the source of risk. This restriction may limit the analysis of other risk components.
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Industry 4.0
There is proof that the case company will undergo the transition to Industry 4.0, so Industry 4.0 as a source of risk is new.
Result
Indicator
:
Application of Industry 4.0 Concepts in the manufacturing.
Ordered Pair
:
(SR, C1)
Risk Type
:
New Risk
Automated Control
Fully Automated Control is one of the components of Industry 4.0. This will be assessed because the case company will apply and
integrate new automated manufacturing controls.
Result
Indicator
:
Application of Fully Automated Processes in the
Production of Sterile Powder for Injections
Ordered Pair
:
(SR, C1)
Risk Type
:
New Risk
Psychological risks
Previous studies found that introducing industrial robots causes workers’ perceived job insecurity, which can lead to increased
mortality and physical or psychological distress [37].
According to Statista, the Philippines is experiencing a surge in the adoption of robotics, particularly in industrial manufacturing.
Over the past years, the industrial robotics market has expanded annually, averaging 10%. According to a market study conducted by
6Wresearch, this is due to the adoption of Industry 4.0 principles, rising labor costs, and the need for more precision in
manufacturing.
Result
Indicator
:
Increase in the introduction of Industrial Robots
Ordered Pair
:
(SR, C4)
Risk Type
:
Increasing Risk
Unemployment
Smart factories are becoming current issues where machine robots perform almost impeccable manufacturing, and the human factor
is minimized in production. Due to the increase in the number of smart factories in the forthcoming period, it is thought that
unskilled laborers will be unemployed.
Medium-sized companies are more likely to adopt Smart Manufacturing technologies [38]. According to the International Trade
Administration report, advanced manufacturing in the Philippines continues to evolve along an upward trajectory, driven by
government support, a skilled workforce, and strategic advantages. While challenges exist, ongoing investments in infrastructure and
a commitment to Industry 4.0 position the Philippines as a promising destination for advanced manufacturing.
Result
Indicator
:
Growing investments and effort for Smart Manufacturing in
th e Philippines
Ordered Pair
:
(SR, C4)
Risk Type
:
Increasing Risk
Need for Qualified Workers
Workers’ perceived job insecurity increases as they become more anxious about the speed of technological development and
automation. Job insecurity is well-known as the cause of workers’ poor mental health [39]. The literature also establishes an
association between workers’ concern over their jobs being replaced by smart machines and job dissatisfaction.
Workers with lower levels of education and who perform routine tasks face the most significant risks of their jobs being automated.
Previous studies estimate that anywhere from 9% to 47% of jobs could be automated.
Result
Indicator
:
Decr ease of employment of unskilled workers
Ordered Pair
:
(CO, C6)
Risk Type
:
Increasing Risk
Invasion of Privacy and Reduced Inter-human Contact
Result
Indicator
:
Application of Industry 4.0 technologies
Ordered Pair
:
(SR, C1)
Risk Type
:
New Risk
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Based on the survey data, Invasion of Privacy and Reduced Inter-human Contact are new to the respondents. However, no significant
factors were identified during the analysis. Given this study's limitations, the sources will be assessed to determine whether they
contribute to the increasing risk. Since no significant factors were identified, Invasion of Privacy and Reduced Inter-human Contact
will be considered New Risks only.
Table 9 Summary of Tichner Results
Source of Risk
Indicators
Ordered
Pair
Risk Type
Industry 4.0
Application of Industry 4.0 Concepts in the
manufacturing.
(SR, C1)
New Risk
Automated Contr ol
(Fully)
Application of Fully Automated Pr ocesses in the
Production of Sterile Powder for Injections
(SR, C1)
New Risk
Psychological Risk
Increase in the introduction of Industrial Robots
(SR, C1),
(SR, C4)
New and
Emerging Risk
Unemployment
Growing in vestments and effort for Smart
Manufacturing in the Philippines
(SR, C1),
(SR, C4)
New and
Emerging Risk
Need for Qualified
Workers
Decr ease of employment of unskilled workers
(SR, C1),
(CO, C6)
New and
Emerging Risk
Invasion of Privacy
Application of Industry 4.0 technologies
(SR, C1)
New Risk
Reduced Inter-human
Contact
Application of Industry 4.0 technologies
(SR, C1)
New Risk
Fig. 9 TICHNER
E. HIRAC Tool
The primary aim of HIRAC is to identify potential risks, evaluate their severity and likelihood, and implement appropriate measures
to minimize or eliminate these risks. The initial step in HIRAC involves identifying hazards. However, in this study, TICHNER was
employed first for the identification and characterization of risk. HIRAC is then employed to thoroughly analyze the risk through
hazard identification. Following hazard identification, the Risk Assessment stage follows. During this step, the severity and
likelihood of each identified hazard are assessed to determine the level of risk it presents. Risks are categorized as high, medium, or
low, allowing organizations to prioritize and address the most critical issues first.
Table 5 Hirac Table
Hazard
Risk
L
S
RR
Control
Unfamiliarity of
Industry 4.0 concepts
Mental
Fatigue
5
4
20
Proper and compreh ensive aining on the
application of Industry 4.0 concepts
before implementation of new processes
Establish a Refresher Training
frequently
Too much information
to understand and cope
on new processes
Mental
Fatigue
5
4
20
Establish a Training Pr ogram and
Schedule on the application of Industry
4.0 concepts
Changes in job roles
and responsibilities
High stress
and anxiety
5
4
20
Cross-training on employees to be
familiarize with different and new
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levels of
new roles
and
responsibilit
ies
processes while integrating a fully
automated system.
Higher rate
of
unemployme
nt of
unskilled
workers
5
4
20
Offer up skilling training for regular
employees especially for machine
operators and inspectors that are closely
in volved in the pr oduction.
Cross-training on employees to be
familiarize with different and n ew
processes while integrating a fully
automated system
No adequate training
regarding th e potential
health risk associated
with industry 4.
High stress
and anxiety
levels
5
4
20
Offer up skilling training for r egular
employees especially for machine
operators and inspectors that are closely
in volved in the pr oduction.
Cross-training on employees to be
familiarize with different and n ew
processes while integrating a fully
automated system.
Job displacement due
to integration of
Industry 4.0
High stress
and anxiety
levels
5
3
15
Cross-training on employees to be
familiarize with different and n ew
processes while integrating a fully
automated system.
Higher rate
of
unemployme
nt of
unskilled
worker
5
4
20
Establish a Training Pr ogram and
Schedule on the application of Industry
4.0 concepts
In demand of new skill
needed for Industry
4.0
Lower
employment
rates of
unskilled
workers
5
4
20
Establish a Training Pr ogram and
Schedule on the application of Industry
4.0 concepts
The severity and likelihood of the Risks were based on answers of the respondents from the survey. To determine the Risk Rating,
the likelihood for each was assigned a rating of 5, possible, assuming that the new and emerging risks will be the result of the
potential hazards. This ensures that the recommended controls are just yet for application. Rating the severity is from the weighted
mean computed from the survey.
From the Hierarchy of Controls, Elimination and Substitution controls concentrate on the primary source of the hazard and find ways
to eliminate it or apply less hazardous processes to minimize the risk. Hence, in this study, both controls cannot be applied because
the main source of the risk in this study would be the application of Industry 4.0 concepts to manufacturing processes. Next in the
hierarchy would be the Engineering Controls. This control is more focused on controlling the process to minimize the risk, thus,
Engineering Controls were not recommended in this study because the study aims to focus on the health and wellness of the
employees when Industry 4.0 concepts are applied. Lastly, the application of Personal Protective Equipment (PPE) was not
recommended because one result of the application of Industry 4.0 is the elimination of humans in the process.
From the controls recommended by the researcher, administrative controls are highly suggested. The involvement of the
Management, Human Resource, and Occupational Safety and Health Committee is highly needed to lower the risks of new and
emerging occupational health risks identified in the study. Comprehensive training and retraining practices for the machine
operators, laboratory operators, and inspectors are very much recommended to control the Psychological Risk, Risk of
Unemployment, and Risk of Need for Qualified Workers.
Since elimination and substitution were not applicable controls for the New and Emerging Occupational Health Risks in the
integration of Industry 4.0, mitigation of these risks will not be immediate. Risks should be reassessed and controls should be
monitored to ensure that they are effective. In this study, the researcher has provided initial steps on the mitigation of these New and
Emerging Occupational Health Risks.
VI. Conclusion
In conclusion, this study presents a set of potential sources of new and emerging risks in the integration of industry 4.0 concepts in a
medium-sized pharmaceutical manufacturing company. The potential sources of new and emerging risks are Physical hazards,
Psychosocial hazards, Ergonomic Hazards, and Insufficient Work experience/ Lack of Knowledge. This study shows that the
common and significant factors contributing to the increasing risk are Insufficient Work Experience/ Lack of Knowledge and
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Psychosocial hazards. The identification, characterization, and analysis of these new and emerging risks were performed through the
use of the TICHNER and HIRAC Tools. The combination of these tools is very efficient in identifying, characterizing, and analyzing
comprehensively the potential risks in the application of Industry 4.0 concepts, especially in the fully automated manufacturing
process.
The New and Emerging Occupational Health Risks identified and characterized by the researcher involve mostly psychological
aspects. With this, controls recommended by the researcher are administrative controls, which mean, management, human resources,
and the OSH Committee must change how people work. Therefore, they should plan and focus on the training and retraining of
machine operators, laboratory operators, and analysts.
Nzioka and Njuguna (2017) provided empirical evidence supporting the notion that effective training programs can positively
influence employees' attitudes toward their jobs and enhance their overall satisfaction and willingness to work. The study also
highlighted the importance of continuous learning opportunities and professional development as key factors in maintaining a
motivated and satisfied workforce [40]. Thus, the application of the recommended administrative controls would lessen workers' job
anxiety and improve their willingness to work because management made an effort not to substitute them with robots.
Another study conducted by Wilson et al. (2017) provides a comprehensive overview of how training and reskilling initiatives can
help mitigate employee anxiety about automation and ensure a more secure and motivated workforce. The study finds that workers
are increasingly anxious about the potential of automation to replace their jobs [41]. To address this anxiety, the authors recommend
comprehensive training and reskilling programs that equip employees with new skills relevant to the evolving technological
landscape. By investing in continuous learning and development, companies can help their employees transition to new roles and
reduce fears about job displacement.
This study shows that the need for a risk assessment when applying new processes is very relevant to planning appropriate controls
for the forthcoming changes in the manufacturing processes.
The results of this study confirm the results of the literature review conducted by Leso et al. (2018), which found that Psychological
risks will become more evident than physical ones in the workplace due to mental overload and work density induced by even more
flexible and dynamic smart manufacturing activities. Furthermore, the study validated that the negative impacts of Industry 4.0 on
the pharmaceutical manufacturing industry gathered from different studies can be a potential source of NERs and significant factors
in increasing the risks.
Recommendation
The study encountered difficulties in gathering data using an online survey. Thus, the study only limited the potential new and
emerging risks and their potential sources. The researcher recommends interviewing the respondents to uncover other new potential
risks.
The researcher also used a literature review to identify, characterize, and analyze new and emerging risks to confirm their existence.
The researcher recommends using company records and documents as indicators in characterizing new and emerging risks and rating
their severity and likelihood.
Administrative Control is the most appropriate control found by the researcher to control the risk. Hence, mitigation of the risk will
not be immediate. The researcher recommends having a determined frequency of risk assessment to monitor if the recommended
controls are effective. The researcher also recommends exploring controls that are process-driven to minimize occupational health
risks
The researcher also recommends the use of the proposed mixed-method approach in different industries integrating Industry 4.0 to
identify, characterize, and analyze not only the Occupational Health Risks but also the Occupational Safety Risks.
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